Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Direct sensitisation data on the mixture are not available. However, as the mixture is corrosive to the skin, such testing would not be justifiable on ethical grounds. As none of the individual components are sensitising agents themselves, there is also no justification scientifically for undertaking further sensitisation studies on this material.

Sensitization data available for the components of the glycol ethers heavies mixture support the conclusion that this material has a low potential for skin sensitization. Patch testing in human volunteers with DPM was negative for skin sensitization. In the mouse LLNA, TPM also displayed a low potential for skin sensitization. Although skin sensitization data for sodium methanolate was not identified, the immediate degradation product, methanol, was negative for skin sensitization when tested in a guinea pig maximization test.


Migrated from Short description of key information:
There is no sensitisation data on the reaction mass itself. The individual components are not known to be sensitising agents. Data from each of the glycol ethers is summarised, and methylate as a corrosive substance cannot be tested directly but is known to hydrolyse rapidly to methanol and sodium hydroxide, neither of which are sensitising. The mixture is therefore not expected to present a sensitising hazard.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the presumed lack of sensitization potential of the mixture, respiratory sensitization is unlikely.


Migrated from Short description of key information:
There is no respiratory sensitisation data on the mixture, but as the individual components do not present skin sensitisation hazards, a respiratory sensitisation hazard is not expected.

Justification for classification or non-classification

Based on the lack of skin sensitization potential for the components of the glycol ethers heavies mixture, the material is not classified for sensitization.